Vaccine mandates more likely once FDA grants full approvals, health experts say

  

Category:  News & Politics

Via:  perrie-halpern  •  2 weeks ago  •  11 comments

By:   Shannon Pettypiece

Vaccine mandates more likely once FDA grants full approvals, health experts say
Americans may be in store for a wave of vaccine mandates from governments, employers and businesses in the coming months once one or more of the Covid-19 vaccines receive full FDA approval.

S E E D E D   C O N T E N T



WASHINGTON — The United States could see a wave of Covid-19 vaccine mandates as soon as the Food and Drug Administration grants full approval to one or more of the shots, public health experts predicted.

The three vaccines authorized by the FDA for emergency use against the coronavirus have proven safe and effective under that expedited review process and in the real world, and doctors and the nation's top public health officials have said there's no need for anyone to wait to get inoculated.

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But as the pace of vaccinations lags and concerns about the highly-contagious delta variant grow, the official regulatory signoff would remove a significant legal and public relations barrier for businesses and government agencies that want to require vaccinations for their employees and customers, former health officials from the Biden and the Obama administrations said.

"I think once the vaccines go through full FDA approval, everything should be on the table, and I think that everything will be on the table at the level of municipalities, states, employers, venues, government agencies," said Andy Slavitt, who stepped down as President Joe Biden's Covid response coordinator last month and remains in close contact with administration officials.

Many institutions, including colleges and universities, have long required certain immunizations. Still, the suggestion of Covid vaccine mandates, whether by local governments for school children or by businesses for their customers, has so far been met with sharp resistance — primarily from conservative lawmakers and activists.

At least 20 state legislatures have passed bills or are considering measures that would ban businesses and state and local governments from placing restrictions on unvaccinated people. Even so, some colleges, concert venues and employers have already started requiring Covid vaccinations.

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But the expedited review process for Covid vaccines has been cited as a safety concern by some people yet to get vaccinated and as a legal hurdle for organizations that have hesitated to put a mandate in place.

Institutions that have put vaccine requirements in place have already faced lawsuits, with opponents arguing that the statute creating the emergency use authorization indicates people should have the option to refuse a treatment. One such lawsuit by health care workers at Houston Methodist was thrown out last month.

But with the new delta variant spreading and hospitals once again filling up, there is a renewed sense of urgency by public health officials to find ways to reach the nearly 1 in 3 eligible Americans who have yet to get their first dose. Pfizer, maker of the first vaccine authorized for emergency use in the United States, said Friday it expects the FDA to grant full approval by January 2022 at the latest. Acting FDA Commissioner Janet Woodcock has said a decision should come well before then.

Health officials said they believe vaccine requirements could be that last push for people who haven't made getting vaccinated a priority or have been indifferent about needing it.

"Shame on us if we sit here in July and don't do something to increase the vaccination rates and then we can't open schools or have a situation where, God forbid, the economy takes another hit because businesses have to shut back down," said Kathleen Sebelius, who served as health and human services secretary under President Barack Obama.

Biden's administration has so far resisted any vaccine requirements, opting instead to offer incentives. But Slavitt said he expects that to change with full FDA approval.

He said he believes some federal agencies should then begin requiring vaccinations for their employees, including members of the military, health care workers at Veterans Affairs hospitals and nursing homes, and other federal workers in close contact with the public, like airport security screeners.

"I think every government agency ought to rethink what's appropriate," Slavitt said. "There are a number of people in surveys, by the way, who say precisely these words, 'I'm not going to take it, unless it's required.'"

White House press secretary Jen Psaki declined to say Friday whether the administration was considering making the vaccine a requirement for the military or the federal workforce. The federal government already requires members of the military to get certain vaccinations. Immigration applicants must also be vaccinated against a range of ailments.

It is unclear how much authority the Biden administration could have as far as requiring vaccinations beyond the federal workforce. No federal vaccination mandate has ever been tested in court and none has ever been issued for the general population. Instead, much of the power to require vaccinations has rested with state and local governments following a Supreme Court ruling in 1905 that upheld a city board of health law requiring all adults get vaccinated against smallpox.

Just a handful of major companies, businesses and venues have put in place any vaccine mandates so far. Delta Air Lines and United Airlines are among the few companies requiring new employees to get vaccinated, but the policy doesn't apply to current employees.

Several other companies, like BlackRock, have said only vaccinated employees can return to the office but have yet to say what will happen with unvaccinated ones. Madison Square Garden and Yankee Stadium have both limited their events to vaccinated attendees, but many other venues have only encouraged guests to get vaccinated.

Even hospitals and nursing homes have been hesitant about making vaccines compulsory for employees. Among nursing home employees, the rate of vaccination is below that of the general population and in some states, including Florida and Georgia, the vaccination rate is under 50 percent for workers, according to data from the Centers for Medicare and Medicaid Services.

"I do think it is a responsibility of employers and others that have the ability to mandate it at their sites," Zeke Emanuel, a health adviser in the Obama administration, said of requiring vaccines for health care workers. "It is not like it is easy, but this is a moment of leadership and sometimes when you are a leader, you have to do hard things."

Hundreds of colleges have required students to be fully vaccinated against Covid before returning to campus, but it's unclear how those mandates will be enforced and there has already been pushback, including lawsuits. A federal judge on Monday upheld Indiana University's vaccine requirement. Most colleges already had vaccine requirements in place for other diseases.

Slavitt said one compromise employers could offer those who are firmly against getting vaccinated would be to requiring them to get tested several times a week.

Biden's administration has been supportive of private companies putting vaccine requirements in place and his chief medical adviser, Dr. Anthony Fauci, said July 11 he believes there should be more vaccine mandates at the local level.

The Biden administration's strategy has focused heavily on trying to make vaccinations more accessible, spreading information about the vaccines and warning about the risks of not getting the shots.

"We know that some employers, hospitals, health systems, colleges, universities and local leaders have chosen to take this step, and we expect others to do so as well," Psaki said regarding vaccine requirements. "But our role we're playing from here is continuing to go community by community, person to person, making sure we are meeting people where they are to get the vaccine out."

Last week the White House turned to the pop star Olivia Rodrigo to try to reach younger people, who have the lowest vaccination rates. The surgeon general also released a report on the influence that misinformation on social media has had on vaccination efforts. Biden said Friday that those social media platforms, including Facebook, were "killing people" by allowing lies about the Covid vaccines to spread on their websites . Hewalked back the criticism Monday, saying those posting the false information were to blame.

The rate of vaccinations has fallen by half since June 1, when the administration declared a "month of action" to redouble efforts as the delta variant spread. By the end of last week, new cases had risen 70 percent over the past seven days with the bulk of infections in four states with relatively low vaccination rates, and the number of deaths had increased by 26 percent to 211 a day, according to the CDC.

"We've got a chance to really continue the progress, the incredible progress that's been made since January," Sebelius said. "But we also have some real warning signs across the world that we should pay close attention to."


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Tacos!
Professor Guide
1  Tacos!    2 weeks ago
At least 20 state legislatures have passed bills or are considering measures that would ban businesses and state and local governments from placing restrictions on unvaccinated people.

That makes no sense. Various employers, and schools from K through college all over the country already require certain vaccines and it’s not even controversial. Suddenly it’s a problem?

 
 
 
Snuffy
Junior Quiet
1.1  Snuffy  replied to  Tacos! @1    2 weeks ago

I think government needs to be careful with this application or they risk creating second-class citizens.  I do agree that every person who is able to should get the vaccine shots but I don't agree with forcing it. They still don't have the full approval yet, the vaccines are still under emergency use authorization. And how many years will it take to get the full authorization?  I would expect the school mandates for this vaccine to go to higher courts just because it doesn't have that full authorization yet.  I think there's still too much knee-jerk reactions to all of this, but that also seems to be how this country operates any more. Little thought is given, rather a one-size fits all mandate is set up.  Just read a story yesterday about a person who lost their college scholarship because the university & state are mandating the vaccines and she should not take them due to a medical condition. Her doctors even sent letters and documentation stating why she should not take the shots. But it didn't matter,  the university had their mandate and that was it. She lost her slot and her scholarship because of a mandate given without allowing for valid exceptions.

There's so much dis-information around it and this virus and the vaccines have been so politicized from the start that it's an uphill climb for everything around it. 

About the only easy one on this I can see is the employer mandates, and even that I think would end up in the courts.  

 
 
 
Tacos!
Professor Guide
1.1.1  Tacos!  replied to  Snuffy @1.1    2 weeks ago
I do agree that every person who is able to should get the vaccine shots but I don't agree with forcing it. They still don't have the full approval yet, the vaccines are still under emergency use authorization.

Fair enough. I don’t like it, but waiting for full authorization is about the only reason I will accept for not getting a shot absent a genuine, serious medical concern.

And how many years will it take to get the full authorization?

Unfortunately, this story doesn’t cover it (it would seem like an obvious addition, but, oh well), so I looked it up elsewhere. According to this article -

When Will the FDA Give Full Approval for COVID-19 Vaccines?  

- we should be seeing some kind of normal approval for Pfizer by January and Moderna by February.

Normally, approval can take years, but it is assumed that the FDA would give these vaccines “priority review” in which case it should be no more than 8 months after the applications were filed. For Pfizer, that was May, and Moderna was June.

Her doctors even sent letters and documentation stating why she should not take the shots. But it didn't matter,

I don’t know if this drove that decision, but I think there is a lot of mistrust now because crazy people have been going around making absurd claims to avoid the shot. Like - the vaccines make you sterile, or they have killed more people than Covid has, or it’s a Bill Gates conspiracy of mind control .

 
 
 
Snuffy
Junior Quiet
1.1.2  Snuffy  replied to  Tacos! @1.1.1    2 weeks ago
- we should be seeing some kind of normal approval for Pfizer by January and Moderna by February. Normally, approval can take years, but it is assumed that the FDA would give these vaccines “priority review” in which case it should be no more than 8 months after the applications were filed. For Pfizer, that was May, and Moderna was June.

If we can get full approval that quickly I think that would be great. A big help for the speed of that approval would be the millions of doses that have been given.  They (The FDA) won't be able to know about the long-term (20 year +) possible issues, but the huge numbers of people that have already gotten the vaccines have to help speed along that full approval. Nothing like a very large test bed for the review.

Her doctors even sent letters and documentation stating why she should not take the shots. But it didn't matter,
I don’t know if this drove that decision, but I think there is a lot of mistrust now because crazy people have been going around making absurd claims to avoid the shot. Like - the vaccines make you sterile, or they have killed more people than Covid has, or it’s a Bill Gates conspiracy of mind control .

Not in this case. She had a very serious reaction to a vaccine two years prior and her doctors advised her against taking the Covid vaccine. That recommendation may change down the road, we hear from a lot of people that the science can change over time. I'm against any one-size fits all solution because there are always exceptions and IMO it's a lazy approach to ignore that exceptions can happen. This girl has had her life turned upside down (including losing $200,000 in scholarship money) and IMO should have grounds to sue and hold the school and the leadership who made the decision to drop her personally accountable.  People who are protected by their employer will never grow and change if they are not held personally accountable for their decisions.

Sandor, whose doctor reportedly wrote an exemption letter — made public by Turning Point USA — on her behalf, shared her story on " Hannity " Monday. She explained how, after being given a vaccine back in 2019, she was diagnosed with Guillain-Barre Syndrome - which left her paralyzed from the waist down for more than a month. 

After receiving word that BYU would be requiring all students to be vaccinated, Sandor’s team of medical providers advised her against being injected with the non-FDA-approved coronavirus vaccine and wrote her a letter of exemption.

Now the people who refuse the shot because of such absurd claims should also have to bear the responsibility of their actions. Because it's more than they are just leaving themselves or their loved ones at risk due to not getting vaccinated, it's keeping the rest of the world at risk due to the continued opportunity for more variants to grow. I don't want to force vaccines on anybody but those who won't get the shots because of their selfish reasons do need to be held accountable for their decisions.  ie,  you have the right to your opinion but that doesn't excuse you from the consequences.

 
 
 
Sparty On
PhD Principal
1.2  Sparty On  replied to  Tacos! @1    2 weeks ago

As an employer i can require such things as a condition of employment.   Folks who don't like it don't have to work here.

We went through this with concealed carry when that got more popular in the 90's.   We could not get insured unless our policy was to NOT allow employees to carry while working and/or on/in our property.   It sucked, we lost good people over it but we were done if we didn't do it.   Uninsurable and therefore unable to operate without it.

Without serious tort reform, this is how it works.

 
 
 
Kavika
Professor Principal
2  Kavika     2 weeks ago

Indiana University's Vaccine Requirement Should Stand, Federal Judge Rules

 
 
 
Ender
Professor Principal
3  Ender    2 weeks ago

People complaining that it shouldn't be forced, it should be a choice.

Bullshit. I bet these same people had a list of immunizations just to attend school.

These idiots need to stop acting like it is the end of the world or some big government conspiracy.

People are trying to save lives and some dopes are fighting it at every turn.

I will not wear a mask, I will not get a shot, I will not stop seeing people...

I swear, half the country has had a few fuses blown never to be replaced.

 
 
 
Paula Bartholomew
Professor Guide
3.1  Paula Bartholomew  replied to  Ender @3    2 weeks ago

On the bright size, these selfish pricks are mostly R's who are dying off.

 
 
 
Ender
Professor Principal
4  Ender    2 weeks ago
@kaitlancollins
An Alabama doctor on treating unvaccinated patients who are dying of Covid-19, and consoling their families afterward. https:// al.com/news/2021/07/i m-sorry-but-its-too-late-alabama-doctor-on-treating-unvaccinated-dying-covid-patients.html
512
 
 
 
Ender
Professor Principal
5  Ender    2 weeks ago
@JohnHammontree
“One of the last things they do before they’re intubated is beg me for the vaccine. I hold their hand and tell them that I’m sorry, but it’s too late.”
512
“And now all you really see is their fear and their regret. And even though I may walk into the room thinking, ‘Okay, this is your fault, you did this to yourself,’ when I leave the room, I just see a person that’s really suffering, and that is so regretful for the choice that they made.”
 
 
 
Nerm_L
Senior Principal
6  Nerm_L    2 weeks ago

Mandate, mandate, who has the mandate?  This is turning into a game of three card monte.  

While Trump was President the scientific message concerning vaccines was cautionary.  Scientists and medical professionals were queued up and paraded across the airwaves by the anti-Trump media.  The vaccines were rushed.  The testing of the vaccines was inadequate.  mRNA vaccines are new and haven't been used before.  The vaccines can't be distributed safely because of their special requirements.  There are allergic reactions.  There are blood clots.  There is heart inflammation.

Amazing how a political election causes the scientific message to flip.  Why is that?

You know, a lot of people have been vaccinated.  Maybe its time to stuff a sock in the science and begin telling the real stories of real people.  Yep, I'm the garbage collector and I'm vaccinated.  It's wasn't a biggie.

IMO now's the time for simple questions rather than expert grandstanding.  These movers, shakers, and central planners complain about social media spreading information they don't like.  But they are totally ignorant of how that information spreads.  To me, now's the time for the experts to shut up and listen. 

Instead of facts, figures, and expert hand waving, all that's required are two questions.  Have you been vaccinated?  What was that like?  Tell me your story, I really want to know.

 
 
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